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Gadopiclenol in Contrast Enhanced MRI of the Prostate

RECRUITINGPhase 4Sponsored by Columbia University
Actively Recruiting
PhasePhase 4
SponsorColumbia University
Started2024-02-14
Est. completion2027-02-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06226129

Summary

The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

* Scheduled to undergo a clinically indicated MRI of the prostate with contrast.
* Scheduled to undergo, or likely to be scheduled to undergo, a prostate MRI-US fusion biopsy with histology results available within 6 months of their MRI.

Exclusion Criteria:

* Prisoner
* Have already begun therapeutic treatment for prostate cancer including surgery (TURP, prostatectomy), radiotherapy, hormone therapy or chemotherapy.
* Patients with end stage renal failure who are on dialysis. Patients who have chronic kidney disease or acute kidney injury are contraindicated for MRI per FDA and ACR (American College of Radiologists) guidelines and would thus be excluded as well.

Conditions2

CancerProstate Cancer

Locations1 site

Columbia University Medical Center
New York, New York, 10032
Nicolas Bloch, MD

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